Indian drug approval mechanism under fire

A report by India's parliamentary committee on the functioning of Central Drugs Standards Control Organization (CDSCO) has raised eyebrows on the drug approval process in the country

Drugs are launched in India without approval

On May 8, when Mr Brajesh Pathak, chairman of India's parliamentary standing committee on health and family welfare, presented its report on the way Central Drugs Standards Control Organization (CDSCO) works, it was akin to opening a can of worms. Although not a major surprise to those in the industry, it did come as a shock to the citizens of the country that at least 33 drugs currently in the market had never been tested on the Indian population.

The 118-page report speaks about the CDSCO, including its motto, the bending of rules for granting approvals to drugs, ignoring of the nexus between doctors and pharma companies and the problems faced by the less than stable office of the drug controller general of India (DCGI). The authors of the report not only explored the inadequacies in the functioning of the CDSCO, but also investigated the malpractices.

The gaps in CDSCO's functioningThere exists many loopholes and several concerns associated with the drug approval system in India.The statutory rules state that "an applicant for new drugs discovered outside India should conduct phase III trials on no less than 100 patients at three-four different hospitals in India to test the efficacy and safety of new drugs for proposed indication". Also, in such cases, the opinion of experts is sought to assess the need and fast track its availability to the Indian population. The post marketing surveillance of such drugs is mandatory. However, there are provisions where in public interest this rule can be waived off. This provision has been provided to allow for faster introduction of necessary vaccines in case of epidemics or life-saving drugs. But analysis has shown that this provision has been grossly misused.

As a part of the report, the standing committee randomly chose 42 drugs to study, which was a sample size of less than two percent of all drugs approved by the DCGI between January 2001 and November 2010. The office of the DCGI could not produce any documents on three of these 42 drugs. Of the remaining 39 drugs, it was found that 11 drugs were given approvals without carrying out the necessary trials. Pharma majors indicted on this account include MNCs such as Novartis, Eli Lilly and GSK and Indian companies like Cipla. Additionally, the committee points out that between January 2008 and October 2010, 33 drugs, which do not fall into the category of emergency medicines, have been approved without conducting the necessary clinical trials.

The main aim behind carrying out a phase III clinical trial for a drug discovered outside India is to test its safety on the Indian population, which is more diverse in terms of genetics than the Caucasian population or any other race on which the drug may have been previously tested. There have been a variety of explanations that have been offered by the DCGI for these trials not being necessitated. (Read more: Some of the comments made by the CDSCO were particularly blatant). The fact that trials were carried out beforehand in other countries which had people of different ethnicities "that could have include Indians"(as stated by the DCGI reply), was one of them though there was no evidence to back this claim.